FDA.reportPublic FDA data

NDC 63443-5057-01 - Nicotine Polacrilex Gum

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63443-5057
Requested NDC
63443-5057-01
Package NDCs from labels
63443-5057-1, 63443-5057-01
Manufacturer
Fertin Pharma A/S
Effective date
2026-02-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Polacrilex Gum - Fertin Pharma A/SFertin Pharma A/S2026-02-18HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63443-5057-1Nicotine Polacrilex Gum10 in 1 CARTONGUM, CHEWING103
63443-5057-1Nicotine Polacrilex Gum10 in 1 BLISTER PACKGUM, CHEWING103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63443-5057NICOTINE POLACRILEX GUM (NICOTINE POLACRILEX) GUM, CHEWING [FERTIN PHARMA A/S]1Current NDC, Legacy NDC, 2 package rows20230106_f1774540-7c2f-c60b-e053-2995a90a1ccb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 9 of 280 · 5,586 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHOLE FOODS MARKET Health Ultra Strength Natural Antacid Peppermint FlavorANTACID TABLETSWHOLE FOODS MARKET, INC.a2dc800d-ac43-4118-9e7b-a55ee7d51c532026-08-11WarningsExact identifier
unii: H0G9379FGK
CAREONE Extra Strength Assorted FruitsCALCIUM CARBONATEFOODHOLD USA2863d17f-b613-4149-8cfb-7f4a1b40fc792026-08-11WarningsExact identifier
unii: H0G9379FGK
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLNice-Pak Products, LLC5b9c19a1-e3c0-4bed-92dd-8bff48477e2e2026-08-10Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLNice-Pak Products, LLCb60be9d4-cf1c-4d4d-b15b-20630b0a4be42026-08-10Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLNice-Pak Products, LLCda4a0e82-b97e-4515-98c6-2c998164a2472026-08-10Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.8d10d75f-e6f6-4029-8640-8cc77c61cfd22026-08-10Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsExact identifier
unii: L7T10EIP3A
Relieve and Relax Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLMAC Innovations, LLCc0528c36-d322-8110-e053-2995a90add6c2026-08-08WarningsExact identifier
unii: L7T10EIP3A
WinCo FOODS Antacid Regular StrengthCALCIUM CARBONATEWINCO FOODS, LLC99ddf630-5be3-4c72-af10-12b62f2491872026-08-07WarningsExact identifier
unii: H0G9379FGK
NicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9ba85e0a-bcb7-4803-8d21-0eb93768cb3a2026-08-07WarningsExact identifier
unii: 6M3C89ZY6R
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
unii: L7T10EIP3A
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
unii: L7T10EIP3A
LidonexLIDOCAINE HCL, MENTHOLAldama Pharmaceuticals, Inc365cf19c-70e0-c4e9-e063-6294a90ac4282026-08-07WarningsExact identifier
unii: L7T10EIP3A
Blaster Pain Relief StickMENTHOL, METHYL SALICYLATE, CAMPHORKalahari Rose, LLC587d660a-5f80-de5a-e063-6394a90aa2872026-08-07WarningsExact identifier
unii: L7T10EIP3A
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
WinCo FOODS Antacid Ultra StrengthCALCIUM CARBONATEWINCO FOODS, LLC4f3a02aa-6534-464e-b1ab-ea8e67a0a77b2026-08-07WarningsExact identifier
unii: H0G9379FGK
WinCo FOODS Antacid Regular strengthCALCIUM CARBONATEWINCO FOODS, LLC3836cb06-7f1a-4cc9-bc03-eb13def449462026-08-07WarningsExact identifier
unii: H0G9379FGK
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLCef9ecb48-b394-4a85-8ba8-aa397d20cd842026-08-07WarningsExact identifier
unii: H0G9379FGK
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLC49bd9752-ddfd-4cb1-bef6-22b4e5b95a372026-08-07WarningsExact identifier
unii: H0G9379FGK
WinCo FOODS Antacid Ultra StrengthCALCIUM CARBONATEWINCO FOODS, LLC1858cf76-cf36-4c56-9e15-14db609aa10f2026-08-07WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.